COVID-19 vaccine candidates report promising results from early and mid-stage clinical trials, but may lack real-world applicability

Sydney, Australia, 10 September 2020—The size and pace of development of the COVID-19 vaccine product pipeline is unprecedented, with the pipeline expanding to more than 200 candidates in less than one year since the discovery of the pathogen in humans, and many of the leading candidates utilising novel vaccine approaches and concepts with limited real-world experience.

In the context of an ongoing global pandemic, understanding the potential of COVID-19 vaccine candidates involves looking not just at their clinical safety and efficacy, but also at other dimensions including ongoing financial investment, manufacturing scale and prospects for global access.

A new analysis by Policy Cures Research of the eight most advanced vaccine candidates compares their safety and immunogenicity profiles (based on published early-stage clinical trial results) with current funding commitments, production targets, advanced purchase commitments, as well as performance against target product profiles for use in outbreak and routine-use settings.

“With so much at stake for the world, obtaining an effective vaccine to fight COVID-19 that everyone can access is critical, if we ever hope to end this pandemic,” said Dr Vipul Chowdhary, Technical Lead at Policy Cures Research. “We believe this is the first analysis that provides an overview of multiple facets of the COVID-19 vaccine development lifecycle. It helps to standardise and decipher the varying presentations (and interpretations) of the findings, and analyse how candidates are progressing in the context of an accelerated development pathway.”

Highlights from the analysis:

• Five of the eight candidates utilise extremely novel vaccine concepts with limited real-world experience, such as replicating and non-replicating viral vectors, or approaches that have never before been approved for use in humans, such as RNA platforms.
• Only one trial reported data on a cohort over 65 years (Pfizer/BioNTech), the highest-risk age group for severe COVID-19 infection. Results showed a significantly lower antibody response in participants between the ages of 65-85 compared to those in the 18-55 age group.
• According to the World Health Organization, a single dose COVID-19 vaccine is ideal, however only one of the eight candidates (CanSino’s adenovirus-vectored vaccine) uses a single dose regimen.
• As the evidence published so far is from a maximum follow-up of 56 days, the durability of protection remains unknown.
• At least three of the candidates – Moderna, Pfizer/BioNTech and Oxford – do not meet the minimum product stability and storage criteria (shelf life of at least 6-12 months as low as -60 to -70°C, and demonstration of at least 2-week stability at 2- 8°C).

About Policy Cures Research
Policy Cures Research is a global health think tank with a long and pioneering history in global health R&D data collection and analysis, securing our position as a trusted source of quality evidence within the sector.

Contact
Mr. Wynne Boelt
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Policy Cures Research
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media@policycuresresearch.org